Institutional Biosafety Committee
STUDY AMENDMENT
Principal Investigator:
Department:
Email:
IBC Study #:
Approved Biosafety Level:
Project Title:
Funding Agency(s)
IBC Amendment #:
Perform a risk assessment per Section II-A-3 of the NIH Guidelines in order to determine the appropriate level of review by the IBC.
Factors to consider include: virulence, pathogenicity, infectious dose, environmental stability, route of spread, communicability,
operations, quantity, availability of vaccine or treatment, and gene product effects such as toxicity, physiological activity, and
allergenicity. Any strain more hazardous than the parent (wild-type) strain should be considered for handling at a higher Biosafety
level. Also consult OSHA requirements for guidance. If the proposed change is considered a major amendment a new research
application must be completed along with this form. If this amendment involves BL2 or above studies, or the addition of new
laboratory locations a laboratory inspection by the Biosafety Officer will be necessary. Submit all materials to IBC@downstate.edu
MINOR AMENDMENT*:
MAJOR AMENDMENT**:
Adding/removing co-investigators (new personnel
Adding/changing organism
should email ibc@downstate.edu that they “have read,
Adding/changing transgene
understood and agreed to participate in the protocol”)
Adding/changing infectious agents
Adding/changing/removing cell lines
Adding/changing/removing transgenic animals
IACUC study #:
IACUC amendment #:
Adding/changing/removing laboratory room numbers:
Upgrade in containment level:
Current Biosafety Level:
Proposed Biosafety Level:
Other
**Submit signed amendment form, AND a signed revised
Current room number(s):
IBC Protocol Submission Form, and any supporting
Proposed room number(s):
documents. The amendment will be considered in a
Other
*Submit amendment form and any supporting documents.
The amendment will be considered by an IBC member for
expedited review.
Describe the proposed change(s) and rationale for the change(s):
convened meeting of the Biosafety Committee.
NOTE TO INVESTIGATORS: Study amendments may not be instituted until approval from the Institutional Biosafety Committee
is given. Retain this form for your records.
Investigator: __________________________________________ Date: _____________________
__________________________________________________________________________________________
The amendment of this project has been reviewed and approved by the Institutional Biosafety Committee.
Authorized IBC Member: ________________________________________Date: __________________
Rev. 04/14